Nivolumab

Generic Name: Nivolumab

Brand Names: Opdivo, Opdualag

Drug Type: Biotech

Chemical Formula: -

CAS Number: 946414-94-4

Unique Ingredient Identifier: 31YO63LBSN

Background: Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. It was developed by Bristol Myers Squibb.

Nivolumab was granted FDA approval on 22 December 2014.

Indication: Nivolumab is indicated to treat unresectable or metastatic melanoma, melanoma as adjuvant treatment, resectable or metastatic non-small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, hepatocellular carcinoma, and esophageal cancer. The indication for classical Hodgkin lymphoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma were approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen.

In combination with relatlimab, nivolumab is indicated for the treatment of patients ≥12 years old with unresectable or metastatic melanoma.

Associated Conditions: Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Advanced Renal Cell Carcinoma, Classical Hodgkin's Lymphoma, Completely resected Stage IIB melanoma, Completely resected Stage III melanoma, Completely resected Stage IV melanoma, Hepatocellular Carcinoma, Locally Advanced Hepatocellular Carcinoma, Locally Advanced Non-Small Cell Lung Cancer, Melanoma, Metastatic Colorectal Cancer (CRC), Metastatic Esophageal Adenocarcinoma, Metastatic Esophageal Squamous Cell Carcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastric Cancers, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Urothelial Carcinoma (UC), Mismatch Repair-deficient (dMMR) Metastatic Colorectal Cancer (CRC), Muscle-invasive Urothelial Carcinoma, Poor Risk Advanced Renal Cell Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, Relapsed or Refractory Classical Hodgkin's Lymphoma, Resectable Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Unresectable Esophageal Squamous Cell Carcinoma, Unresectable Locally Advanced Urothelial Cancer, Unresectable Melanoma, Urothelial Carcinoma, Completely resected Stage IIC melanoma, Intermediate risk Advanced Renal Cell Cancer, Locally advanced Urothelial Carcinoma, Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic gastroesphageal juntion adenocarcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Relapsed Classical Hodgkin's Lymphoma, Residual Esophageal Cancer, Residual Gastroesophageal Junction Cancer, Unresectable Malignant Pleural Mesothelioma (MPM), Unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma, Unresectable, advanced Esophageal Squamous Cell Carcinoma (ESCC), Unresectable, metastatic Esophageal Squamous Cell Carcinoma (ESCC), Unresectable, recurrent Esophageal Squamous Cell Carcinoma (ESCC)

Associated Therapies: Complete Surgical Resection, Neoadjuvant Therapies

Clinical Trials

Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy

Phase 2

Active, not recruiting

Conditions: Biliary Tract Cancer

Interventions: Drug: Rucaparib
Drug: Nivolumab

First Posted Date: 2018-08-21

Last Posted Date: 2024-08-21

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 32

Registration Number: NCT03639935

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States
🇺🇸
Rogel Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2018-08-20

Last Posted Date: 2024-01-23

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 31

Registration Number: NCT03637543

Locations: 🇺🇸
DFCI South Shore, South Weymouth, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
St. Elizabeth's Medical Center, Boston, Massachusetts, United States

and more 2 locations

A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102

Phase 1

Completed

Conditions: Glioblastoma

Interventions: Biological: Ad-RTS-hIL-12
Drug: veledimex
Drug: Nivolumab

First Posted Date: 2018-08-17

Last Posted Date: 2021-10-04

Lead Sponsor: Alaunos Therapeutics

Target Recruit Count: 21

Registration Number: NCT03636477

Locations: 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States

and more 1 locations

A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma
Unclassified Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Fumarate Hydratase Deficient Renal Cell Carcinoma
Succinate Dehydrogenase Deficient Renal Cell Carcinoma
Collecting Duct Renal Cell Carcinoma
Chromophobe Renal Cell Carcinoma

Interventions: Drug: cabozantinib
Drug: nivolumab

First Posted Date: 2018-08-17

Last Posted Date: 2024-05-22

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 60

Registration Number: NCT03635892

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer
Urothelial Carcinoma
Squamous Cell Carcinoma of the Head and Neck
Cutaneous Melanoma
Renal Cell Carcinoma

Interventions: Biological: GEN-009 Adjuvanted Vaccine
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2018-08-16

Last Posted Date: 2022-04-19

Lead Sponsor: Genocea Biosciences, Inc.

Target Recruit Count: 24

Registration Number: NCT03633110

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
John Wayne Cancer Institute - Providence Saint John's Health Center, Santa Monica, California, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 8 locations

Neoadjuvant and Adjuvant Nivolumab in HCC Patients Treated by Electroporation

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Nivolumab Injection [Opdivo]

First Posted Date: 2018-08-15

Last Posted Date: 2024-07-31

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 43

Registration Number: NCT03630640

Locations: 🇫🇷
Hôpital Jean Verdier, Bondy, France

Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma

Phase 1

Active, not recruiting

Conditions: Osteosarcoma Recurrent
Sarcoma
Osteosarcoma in Children
Osteosarcoma

Interventions: Drug: Nivolumab
Drug: Azacitidine
Procedure: Post Treatment Surgery

First Posted Date: 2018-08-14

Last Posted Date: 2025-01-01

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 21

Registration Number: NCT03628209

Locations: 🇺🇸
Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States

and more 19 locations

Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma

Phase 2

Completed

Conditions: Melanoma Stage Iii
Melanoma Stage Iv
Cutaneous Melanoma
Melanoma
Melanoma (Skin)

Interventions: Drug: Denosumab
Drug: Pembrolizumab
Drug: Nivolumab

First Posted Date: 2018-08-08

Last Posted Date: 2024-08-12

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 25

Registration Number: NCT03620019

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Manchester, New Hampshire, United States
🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer

Phase 1

Active, not recruiting

Conditions: Immune Checkpoint Inhibition
Gastroesophageal Cancer

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2018-08-01

Last Posted Date: 2024-12-11

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 21

Registration Number: NCT03610711

Locations: 🇺🇸
Alleghany Health Network, Pittsburgh, Pennsylvania, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Baylor University, Dallas, Texas, United States

Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Phase 2

Recruiting

Conditions: MSI-H Tumors
Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy

Interventions: Drug: Nivolumab
Drug: Relatlimab

First Posted Date: 2018-07-31

Last Posted Date: 2024-10-23

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 42

Registration Number: NCT03607890

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy